A Pharmacokinetic Study to Characterize JNJ-39393406 in the Cerebrospinal Fluid of Healthy Volunteers

NCT01556217 | Completed Phase 1

• 3 other identifiers: CR01740439393406ALZ10042010-022062-26
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the concentration of JNJ-39393406 achieved in the blood and cerebrospinal fluid of healthy adult volunteers following administration of a single dose of JNJ-39393406.

Conditions

Healthy Volunteers

Keywords

Healthy volunteers; JNJ-39393406-aaa; Pharmacokinetics; Central brain penetrance; Cerebral spinal fluid

Outcome Measures

Primary Outcomes (2)

• Plasma concentration of JNJ39393406

  At 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 16, 20 and 24 hours post dose

• Cerebral spinal fluid (CSF) concentration of JNJ39393406

  At 0:30, 1, 1:30, 2, 2:30, 3, 3:30, 4, 6, 8, 10, 12, 16, 20 and 24 hours post dose

Secondary Outcomes (1)

• Incidence of adverse events as a measure of safety and tolerability

  Approximately 6 weeks

Study Arms (2)

JNJ-39393406

EXPERIMENTAL

Drug: JNJ-39393406

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JNJ-39393406 DRUG

Type= exact number, Unit= mg, Number= 200, Form= oral suspension, Route= oral administration. Oral suspension to be taken once with 240 mL (8 ounces of water) between 8:00 AM and 10:30 AM.

JNJ-39393406

Placebo DRUG

Form= oral suspension, Route= oral administration. Oral suspension to be taken once with 240 mL (8 ounces of water) between 8:00 AM and 10:30 AM.

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female volunteers must be postmenopausal (for at least 12 months)
• Body mass index (BMI) between 18 and 29.9 kg/m2, inclusive
• Healthy on the basis of physical examination, neurological examination, medical history, vital signs, and 12-lead ECG \[including QTcB interval duration \<450 msec\] performed at screening. Minor deviations in ECG, which are not considered to be of clinical significance to the investigator, are acceptable
• Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel \[including liver enzymes\], hematology, or urinalysis are outside the normal reference ranges, the volunteer may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant

You may not qualify if:

• History of liver or renal insufficiency
• significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Relevant history of or current neurological disease including any history of post dural puncture headache, lower back pain or scoliosis and/or major (lumbar) back surgery, spontaneous, prolonged or severe bleeding with unclear origin, epilepsy or fits or unexplained black-outs
• History or family history of abnormal bleeding or of blood clotting or anemia

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Interventions

JNJ-39393406

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2011
• First Posted: March 16, 2012
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 24, 2013

Record last verified: 2013-07